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Realisation of the Study

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Realisation of the Study LAKANA trial A research plan for a cluster-randomized, double-blinded, parallel group, controlled trial, testing the effects of mass-drug administration of azithromycin on mortality and other outcomes among 1-11 month old infants in rural Mali Principal and co-principal investigators (in alphabetical order) Per Ashorn, MD, PhD 1 Ulla Ashorn, PhD 1 Yin Bun Cheung, PhD 1,2 Camilla Ducker, MBBS, MSc 3 Nigel Klein, MBBS, PhD 4 Samba O Sow, MD, MSc, FASTMH 5 Participating Academic Institutions 1Center for Child Health Research, Tampere University, Faculty of Medicine and Health Technology, Tampere, Finland 2Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore 3Tro Da Ltd, UK 4University College London, UK 5CVD-Mali, Bamako, Mali Contact information: Per Ashorn, MD, PhD, Center for Child Health Research, Tampere University, Faculty of Medicine and Health Technology, Tampere Finland Tel. +358 40 7280 345, E-mail: [email protected] Protocol version 2.0: 17. December 2019 Trial protocol: LAKANA Page 2 / 89 Table of contents 1. PROTOCOL VERSION HISTORY ...................................................................... 4 2. EXECUTIVE SUMMARY ..................................................................................... 5 2.01. ADMINISTRATIVE INFORMATION ........................................................................ 5 2.02. KEY DETAILS OF THE TRIAL ................................................................................ 6 3. BACKGROUND ..................................................................................................... 8 3.01. HEALTH PROBLEM TO BE ADDRESSED ................................................................. 8 3.02. STUDY OBJECTIVE ............................................................................................. 8 3.03. BACKGROUND TO AND JUSTIFICATION FOR THE STUDY ........................................ 8 3.04. POTENTIAL PUBLIC HEALTH EFFECTS .................................................................. 9 3.05. DISTRIBUTION OF THE RESULTS ........................................................................ 10 4. THE STUDY ......................................................................................................... 10 4.01. OBJECTIVES OF THE PROPOSED RESEARCH ........................................................ 10 4.02. DETAILED STUDY QUESTIONS ........................................................................... 11 4.03. STUDY SITE AND TARGET POPULATION ............................................................. 12 4.04. STUDY DESIGN ................................................................................................ 13 4.05. ENROLLMENT CRITERIA FOR PARTICIPATING CLUSTERS AND PARTICIPANTS ....... 13 4.06. TRIAL INTERVENTIONS AND CONTROL .............................................................. 14 4.07. OUTCOME VARIABLES...................................................................................... 15 4.08. DATA COLLECTION SITES FOR VARIOUS OUTCOMES ........................................... 16 4.09. SCHEDULE AND PROCEDURES FOR PARTICIPANT ENROLLMENT AND FOLLOW-UP 17 4.10. EXPECTED RECRUITMENT AND LOSS-TO-FOLLOW-UP RATES .............................. 19 4.11. PURCHASE, FORMULATION, STORAGE, AND DISTRIBUTION OF STUDY DRUGS ...... 19 4.12. DATA COLLECTION ON INFANT AND CHILD MORTALITY ..................................... 20 4.13. ADAPTIVE DESIGN: POSSIBLE CHANGES AFTER INTERIM ANALYSES .................... 21 4.14. DATA COLLECTION ON INFANT MORBIDITY ....................................................... 23 4.15. DATA COLLECTION ON INFANT GROWTH AND NUTRITIONAL STATUS .................. 23 4.16. DATA COLLECTION ON ANTIMICROBIAL RESISTANCE ......................................... 24 4.17. DATA COLLECTION ON MECHANISMS OF ACTION FOR AZITHROMYCIN ................ 28 4.18. STAKEHOLDER PERSPECTIVES ON FEASIBILITY, ACCEPTABILITY AND EQUITY ..... 34 4.19. DATA COLLECTION ON TRIAL SAFETY ............................................................... 36 4.20. GROUP ALLOCATION AND TRIAL CODE MANAGAMENT ...................................... 37 4.21. METHODS FOR PROTECTING AGAINST OTHER SOURCES OF BIAS ......................... 37 4.22. WITHDRAWAL FROM PARTICIPATION AFTER ENROLLMENT ................................ 38 4.23. OTHER TREATMENTS TO TRIAL PARTICIPANTS ................................................... 38 4.24. CO-ENROLLMENT GUIDELINES ......................................................................... 38 4.25. STORAGE OF BIOLOGICAL SAMPLES .................................................................. 38 4.26. DATA RECORDING AND MANAGEMENT ............................................................. 39 4.27. PILOT STUDY ................................................................................................... 40 4.28. QUALITY ASSURANCE AND CONTROL................................................................ 40 4.29. TIME SCHEDULE .............................................................................................. 40 5. STATISTICAL CONSIDERATIONS AND DATA ANALYSIS ........................ 42 Protocol version 2.0: 17. December 2019 Trial protocol: LAKANA Page 3 / 89 5.01. SPECIFIC HYPOTHESES ..................................................................................... 42 5.02. ANALYTICAL APPROACH .................................................................................. 43 5.03. FREQUENCY OF ANALYSES ............................................................................... 45 5.04. SAMPLE SIZE AND ITS JUSTIFICATION ................................................................ 45 5.05. SUBGROUP ANALYSES ...................................................................................... 47 6. ETHICAL CONSIDERATIONS .......................................................................... 47 6.01. GENERAL PRINCIPLES ...................................................................................... 47 6.02. INFORMED CONSENT ........................................................................................ 47 6.03. POSSIBLE RISKS AND BENEFITS TO STUDY PARTICIPANTS ................................... 48 6.04. AMOUNT OF COLLECTED BLOOD AND OTHER BIOSPECIMENS .............................. 49 6.05. INSURANCE COVERAGE .................................................................................... 50 6.06. COMPENSATION TO STUDY PARTICIPANTS ......................................................... 50 6.07. PAYMENTS TO THE TRIAL ORGANISERS ............................................................. 50 6.08. DATA SAFETY AND MONITORING BOARD (DSMB) ............................................ 50 6.09. STOPPING RULES FOR THE STUDY ..................................................................... 51 7. PERSONNEL, RESOURCES, AND STUDY MANAGEMENT ........................ 52 7.01. RESEARCH INSTITUTIONS ................................................................................. 52 7.02. PRINCIPAL INVESTIGATORS .............................................................................. 52 7.03. STUDY STATISTICIANS ..................................................................................... 54 7.04. OTHER MAIN SCIENTISTS AND THEIR RESPONSIBILITIES ..................................... 54 7.05. OTHER EMPLOYED STAFF ................................................................................. 54 7.06. ARRANGEMENTS FOR DAY-TO-DAY MANAGEMENT OF THE STUDY ..................... 55 7.07. COMMUNICATION PLAN ................................................................................... 56 7.08. PROJECT STEERING GROUP .............................................................................. 56 7.09. NATIONAL AND INTERNATIONAL ADVISORY GROUPS ......................................... 56 8. TRAINING PROVIDED ...................................................................................... 57 9. POSSIBLE CONSTRAINTS ................................................................................ 57 10. FUNDING ............................................................................................................ 58 11. REFERENCES .................................................................................................... 59 12. APPENDICES ..................................................................................................... 65 APPENDIX 1A: INFORMATION ABOUT THE TRIAL TO VILLAGE LEADERSHIP .................. 65 APPENDIX 1B: VERBAL CONSENT FORM FOR VILLAGE PARTICIPATION ...................... 71 APPENDIX 2A: INFORMATION ABOUT THE TRIAL TO A POTENTIAL PARTICIPANT .......... 72 APPENDIX 2B: VERBAL HOUSEHOLD CONSENT FORM FOR TRIAL PARTICIPATION ....... 78 APPENDIX 3: CONSENT TO PROVIDE STUDY MEDICINE TO AN INDIVIDUAL INFANT ....... 79 APPENDIX 4A: INFORMATION ON SECONDARY OUTCOME DATA COLLECTION .............. 81 APPENDIX 4B: CONSENT FORM FOR PARTICIPATION IN LAKANA SUB-STUDIES......... 86 Protocol version 2.0: 17. December 2019 1 1. Protocol version history 2 DATE ISSUED AUTHOR/S DETAILS OF CHANGES MADE SUBMITTED APPROVED SUBMITTED APPROVED OF TO IRB, AT IRB , TO IRB , TAU AT IRB, TAU CHANGES MALI (DATE) MALI (DATE) (DATE/NO) (DATE/NO) AMENDME NO. NT PROTOCOL VERSION# 1.0 27.11.2019 Ashorn First complete protocol draft. Submitted for IRB review but 29.11.2019 Withdrawn N / A N / A withdrawn by the research team for further edits 1 2.0 17.12.2019 Ashorn Expanded the trial area: Earlier only Kayes region, now parts of 17.12.2019 Kayes, Kita, and Koulikoro regions. Removed the
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